- Olympus Corporation of the Americas (Center Valley, PA)
- …+ Interpret statistical results; collaborate with cross-functional teams (clinical operations, regulatory affairs , medical writing, data management) to ... Data Management and Systems collaborating closely with MCA - Medical Affairs and Clinical Affairs ...including different evidence generation programs. + Ensure compliance with regulatory standards relevant to medical devices (eg,… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …US strategy, operational oversight, and performance management of the Rare Disease Field Medical Affairs (FMA) team. This role manages the unique challenge of ... policy teams to ensure strategy reflects patient perspectives. The Director is responsible for medical customer engagement,...from the field to inform internal strategic decision-making within Medical Affairs and across the broader R&D… more
- Merck (North Wales, PA)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... to pursue and subsequent study design, initiation, execution, monitoring, analysis, regulatory filing, and publication. **Specifically, The Senior Director May… more
- West Pharmaceutical Services (Williamsport, PA)
- …and manages quality control, quality assurance, quality systems, metrology and/or regulatory affairs , personnel, department resources, and continuous improvement ... medical device manufacturing. **Preferred Knowledge, Skills and Abilities** + ** Regulatory Skills:** In-depth knowledge of medical device and pharmaceutical… more
- Merck (Upper Gwynedd, PA)
- …+ Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... to pursue and subsequent study design, initiation, execution, monitoring, analysis, regulatory filing, and publication. **Specifically, The Clinical Director May… more
- University of Pennsylvania (Philadelphia, PA)
- …protocol-required tests and procedures. + Assist with completing and maintaining regulatory correspondence under the direction of research director . Participate ... for industry sponsored studies. Works directly with study physicians, research director and other research staff. Major duties include screen/enroll patients,… more
- University of Pennsylvania (Philadelphia, PA)
- …of medical information from charts into online databases 2. Regulatory - preparation, submission and monitoring of human subject's protocols, and progress reports ... of medical information from charts into online databases 2. Regulatory - preparation, submission and monitoring of human subject's protocols, and progress reports… more
- Penn Medicine (Philadelphia, PA)
- …clinical trials + All other responsibilities as designated by Manager, Administrative Director or Chair. ** Regulatory Compliance (15% of Operations weight)** + ... leaders in the field of medicine. Working for this leading academic medical center means collaboration with top clinical, technical and business professionals across… more
- Pfizer (Collegeville, PA)
- …Congress Strategy lead and cross functionally across Congress and Ad Board Excellence, Medical Affairs , external agency partners and other departments as needed ... to be. This role will report directly to the Director , Commercial Congress Strategy Team Lead. **ROLE RESPONSIBILITIES** The...with various commercial teams, Congress and Ad Board Innovation, Medical Affairs + Develop, maintain and manage… more
- Sumitomo Pharma (Harrisburg, PA)
- …ensure system validation is maintained. + Work closely with Clinical Operations and Regulatory Affairs to ensure compliance with regulatory requirements. + ... (TMFs) ready for audits and inspections. Partnering with the Associate Director , Clinical Business Operations, the specialist ensures accountable functions follow… more